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HIV lipodystrophy syndrome is associated with both metabolic (e.g., dyslipidemia and insulin resistance) and anthropomorphic (e.g., lipoatrophy and central obesity) abnormalities. These defects are likely to predispose HIV patients on highly active antiretroviral therapy (HAART) to accelerated cardiovascular morbidity. Based on studies of key mechanisms of altered lipid kinetics in these patients, evidence that DE patterns of patients with HIV lipodystrophy are inadequate to manage cardiovascular risk factors, and current recommendations for treatment of atherosclerosis and insulin resistance, the following is hypothesized: 1) an intensive lifestyle intervention with DE will improve the plasma lipid profile, decrease visceral fat mass, and improve hormonal, metabolic, and lipoprotein markers associated with insulin resistance; and 2) adding niacin, fenofibrate, or a combination of the two drugs to the intensive lifestyle intervention will result in further improvement in the cardiovascular risk profile.

DESIGN NARRATIVE:

This randomized, placebo-controlled study of 200 hypertriglyceridemic HIV patients on stable HAART treatment has the following specific aims: 1) to compare the effects of usual care, intensive DE, DE plus niacin, DE plus fenofibrate, and DE plus niacin plus fenofibrate on fasting plasma lipid concentrations (primary endpoint); 2) to compare the effects of the five treatment protocols on body fat distribution; and 3) to compare the effects of the five treatment protocols on hormonal, lipoprotein, and metabolic markers of insulin resistance. The collaborative team has expertise in lipid and lipoprotein metabolism, innovative and effective diet modification programs, intensive exercise programs in HIV patients, and studies of antilipidemic and antiretroviral agents. Therefore, this study will determine the efficacy of DE, with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV positive

On stable HAART regimen for at least 6 months prior to study entry

T-cell count greater than 100 and viral load less than 1,000 for at least 6 months prior to study entry

Fasting triglyceride level greater than 150 mg/dl

Body mass index (BMI) greater than 18.5 and less than 30

Uses barrier contraception

Exclusion Criteria:

Fasting triglyceride level greater than 1000 mg/dl

BMI less than 18.5 or greater than 30

Taking diabetic medication or HbA1c less than 7.0

Use of lipid lowering medication in the 30 days prior to study entry

Unable to exercise

T-cell count less than 100

Current medical condition that makes exercise unadvisable

History of coronary artery disease (CAD)

Use of dietary supplements (within 30 days of study entry) that may affect lipid levels including, but not limited to, the following:

Omega-3 fatty acids

L-Carnitine

Soluble fiber supplements

Guggul

Garlic supplements

Niacin greater than 25mg/d

Oral liquid supplements

Use of steroids, hormones, or testosterone (without diagnosis of hypogonadism, testosterone less than 300 ng/dl)

Irregular periods

Depo-Provera

Hypo- or Hyperthyroidism

Adrenal insufficiency

Serum alanine or aspartate aminotransferase level greater than 3 times the upper limit of normal